<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936415992101</udiDi>
    <basicUdiDi>B-06936415992101</basicUdiDi>
    <tradeName>S30 CALIBRATOR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0031-30-60733</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:10.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415992118</udiDi>
    <basicUdiDi>B-06936415992118</basicUdiDi>
    <tradeName>S50 Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0031-30-84525</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:10.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415992125</udiDi>
    <basicUdiDi>B-06936415992125</basicUdiDi>
    <tradeName>S50 Calibrator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010507</emdnCode>
    <emdnDescription>WHOLE BLOOD CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0031-30-84526</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:10.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415992170</udiDi>
    <basicUdiDi>B-06936415992170</basicUdiDi>
    <tradeName>B55 HEMATOLOGY CONTROLS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000124-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:10.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415992187</udiDi>
    <basicUdiDi>B-06936415992187</basicUdiDi>
    <tradeName>B55 HEMATOLOGY CONTROLS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000125-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:10.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415992194</udiDi>
    <basicUdiDi>B-06936415992194</basicUdiDi>
    <tradeName>B55 HEMATOLOGY CONTROLS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000126-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:10.422Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415994341</udiDi>
    <basicUdiDi>B-06936415994341</basicUdiDi>
    <tradeName>BR60 Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-009064-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:08.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415994389</udiDi>
    <basicUdiDi>B-06936415994389</basicUdiDi>
    <tradeName>BR60 Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-009068-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:08.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415994426</udiDi>
    <basicUdiDi>B-06936415994426</basicUdiDi>
    <tradeName>BR60 Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-009072-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:08.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415994433</udiDi>
    <basicUdiDi>B-06936415994433</basicUdiDi>
    <tradeName>BR60 Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-009073-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:08.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415994440</udiDi>
    <basicUdiDi>B-06936415994440</basicUdiDi>
    <tradeName>BR60 Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-009074-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:08.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415994686</udiDi>
    <basicUdiDi>B-06936415994686</basicUdiDi>
    <tradeName>B55 HEMATOLOGY CONTROLS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-011161-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:08.290Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415994709</udiDi>
    <basicUdiDi>B-06936415994709</basicUdiDi>
    <tradeName>B55 HEMATOLOGY CONTROLS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-011193-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:08.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936415994723</udiDi>
    <basicUdiDi>B-06936415994723</basicUdiDi>
    <tradeName>B55 HEMATOLOGY CONTROLS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-011195-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:10:08.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0270100UY</udiDi>
    <basicUdiDi>B-0270100UY</basicUdiDi>
    <tradeName>möLab® OneSecond Multi-Dip Test 10-fach (AMP,BAR,BZD,COC,THC,MET,MTD,MOR,PCP,TCA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0270100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:05:47.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0270099W8</udiDi>
    <basicUdiDi>B-0270099W8</basicUdiDi>
    <tradeName>möLab® OneSecond Multi-Dip Test 10-fach (AMP,BAR,BZD,COC,THC,MET,MTD,MOR,TCA,MDMA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0270099</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:05:47.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0270092VS</udiDi>
    <basicUdiDi>B-0270092VS</basicUdiDi>
    <tradeName>möLab® OneSecond Multi-Dip Test 11-fach (AMP,BAR,BUP.BZD,COC,MDMA,THC,MET,MTD,MOR,TCA)</tradeName>
    <deviceName>möLab® OneSecond Multi-Dip Test 11-fach (AMP,BAR,BUP.BZD,COC,MDMA,THC,MET,MTD,MOR,TCA)</deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0270092</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:05:45.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0270091VQ</udiDi>
    <basicUdiDi>B-0270091VQ</basicUdiDi>
    <tradeName>möLab® OneSecond Multi-Dip Test 10-fach (AMP,BZD,COC,THC,MET,MTD,MOR,TCA,MDMA,BUP)</tradeName>
    <deviceName>möLab® OneSecond Multi-Dip Test 10-fach (AMP,BZD,COC,THC,MET,MTD,MOR,TCA,MDMA,BUP)</deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0270091</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:05:45.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0270067VT</udiDi>
    <basicUdiDi>B-0270067VT</basicUdiDi>
    <tradeName>möLab® OneSecond Multi-Dip Test 7-fach (AMP, BZD,COC,THC,MET,MTD,MOR)</tradeName>
    <deviceName>möLab® OneSecond Multi-Dip Test 7-fach (AMP, BZD,COC,THC,MET,MTD,MOR)</deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0270067</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:05:29.907Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0270044VF</udiDi>
    <basicUdiDi>B-0270044VF</basicUdiDi>
    <tradeName>möLab® OneSecond Multi-Dip Test 8-fach (AMP,BZD,COC,THC,MTD,MOR,BUP,EDDP)</tradeName>
    <deviceName>möLab® OneSecond Multi-Dip Test 8-fach (AMP,BZD,COC,THC,MTD,MOR,BUP,EDDP)</deviceName>
    <manufacturerName>möLab GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022941</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0270044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T21:05:29.107Z</lastUpdated>
  </row>
</eudamedExport>